Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Procter & Gamble Company · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
147 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203567 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2021-04-05 | 119 | 0 |
| K201277 | Oral-B Dry Mouth Oral Rinse | The Procter & Gamble Company | 2020-09-02 | 112 | 0 |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | The Procter & Gamble Company | 2020-08-27 | 147 | 0 |
| K133244 | TAMPAX M PLASTIC TAMPONS, UNSCENTED | The Procter & Gamble Company | 2014-01-09 | 79 | 0 |
| K113699 | TAMPAX(R) V PLASTIC APPLICATOR TAMPONS, UNSCENTED | The Procter & Gamble Company | 2012-01-12 | 27 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda